Granuflo Class Action Lawsuit Filed Over Fresenius Dialysis Treatment

Fresenius Medical Care faces a class action lawsuit in Pennsylvania, brought on behalf of individuals who suffered sudden heart complications during dialysis treatments involving the company’s GranuFlo solution, which has been linked to hundreds of deaths in recent years.

The complaint was filed by Carmen Brysten in the Philadelphia Court of Common Pleas on June 14, seeking class action status to include all Pennsylvania residents who received GranuFlo dialysis treatment and suffered a cardiac arrest, sudden heart-related death or cardiac events.

Brysten brought the Granuflo class action lawsuit following the death of her husband, Filmon Brysten, in November 2011. That same month, Fresenius issued an internal memo to doctors at their own dialysis clinics warning about the risk of problems with Granuflo, which may increase bicarbonate levels to higher than expected levels and cause users to suffer a sudden heart attack or death.

“Based on the knowledge readily available to the medical community as early as 2004, Fresenius knew or should have known of the increased risk of metabolic alkalosis attributed to the use of GranuFlo long before the publication of its November 4, 2011 internal memorandum detailing the problem to Fresenius physicians and clinics,” the lawsuit states. “Despite this knowledge, Fresenius failed to inform physicians that GranuFlo increases the level of bicarbonate in patients, thus preventing physicians and/or clinicians from learning of the need to reduce the bicarbonate prescribed to patients undergoing dialysis with GranuFlo.”

Although Fresenius provided an internal memo to their own clinics in November 2011, the company failed to provide similar warnings to other dialysis centers that used Granuflo. After the internal memo was leaked to the FDA, Fresenius did issue a public warning in March 2012, which the FDA classified as a Granuflo recall.

Fresnius Lawsuits Over Granuflo Dialysis Treatments

Fresenius Medical Care owns and operates thousands of dialysis clinics throughout the United States. However, the company also manufactures dialysis products and machines used at other centers.

Granuflo is a dry acid concentrate that has been commonly used during hemodialysis treatments throughout the United States. A similar product is marketed by Fresenius as NaturaLyte, which is a liquid acid concentrate.

Side effects of Granuflo and Naturalyte require doctors to carefully monitor patient bicarbonate levels during treatments. The manufacturer has been accused of withholding the information from the medical community, resulting in sudden cardiac arrest during or shortly after hemodialysis.

In addition to the class action lawsuit in Pennsylvania, Fresenius faces more than 160 GranuFlo dialysis treatment lawsuits have been filed in federal courts nationwide. 

In March, the U.S. Judicial Panel on Multidistrict Litigation issued an order consolidating the federal court Fresenius dialysis treatment litigation before U.S. District Judge Douglas P. Woodlock in the District of Massachusetts, where the cases will be coordinated during pretrial proceedings as part of an MDL or multidistrict litigation. It is ultimately expected that hundreds, if not thousands, of cases are likely to be filed over problems with Granuflo or NaturaLyte.